Efalizumab in the Treatment of Alopecia, Phase II

NCT00746980 | Withdrawn Phase 2 DMC

• 1 other identifier: 20070823
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Determine the effect that treatment with efalizumab has on scalp hair re-growth in younger adults affected by severe variants of alopecia areata, including alopecia totalis, alopecia universalis, and severe ophiasis variants.

Conditions

Alopecia Totalis

Keywords

alopecia; areata; universalis; severe; ophiasis; variants

Outcome Measures

Primary Outcomes (1)

• Percentage re-growth of scalp hair loss

  1 year

Secondary Outcomes (3)

• Self-assessment (SA) and Static physician global assessment (SPGA)

  1 year

• Body hair re-growth at 48 weeks

  1 year

• Quality of life questionnaire

  48 weeks

Study Arms (1)

Treatment

EXPERIMENTAL

Subjects receiving drug

Drug: efalizumab

Interventions

efalizumab DRUG

1 mg/kg subcutaneously once weekly for 48 weeks, following an initial conditioning dose of 0.7 mg/kg at week 0.

Also known as: Raptiva

Treatment

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• ability to provide written informed consent and comply with study assessments for the full duration of the study.
• clinical diagnosis of alopecia totalis, alopecia universalis, or severe ophiasis variant of alopecia areata.
• years of age.
• if a female of childbearing potential, a negative pregnancy test and commitment to the use of two forms of effective contraception (birth control) for the duration of the study are necessary.
• if a non-sterile male, commitment to the use of two forms of effective contraception (birth control) for the duration of the study is necessary.

You may not qualify if:

• known hypersensitivity to efalizumab (Raptiva) or any of its components.
• known liver disease, including active hepatitis
• history of autoimmune diseases causing alopecia other than alopecia areata.
• prior biologic therapy within 6 months prior to study initiation.
• history of any malignancy within last ten years, except treated non-melanoma skin cancers.
• any woman currently pregnant or lactating.
• intake of systemic immunosuppressive agents, including oral corticosteroids, within 3 months prior to study initiation.
• history of positive PPD and/or tuberculosis.
• history of HIV/AIDS
• prior enrollment in any efalizumab study
• any condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated.
• participation in another simultaneous clinical trial involving investigational agents.
• positive HIV screening test obtained at screening visit.
• positive QuantiFERON-TB test obtained at screening visit.
• positive hepatitis screen obtained at screening visit.

Sponsors & Collaborators

• Northwestern University: lead
• Genentech, Inc.: collaborator

MeSH Terms

Conditions

Alopecia; Lymphoma, Follicular

Interventions

efalizumab

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Dennis West, PhD

  Northwestern University, Department of Dermatology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Dermatology and Pediatrics

Study Record Dates

• First Submitted: September 2, 2008
• First Posted: September 4, 2008
• Study Start: August 1, 2008
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: June 14, 2016

Record last verified: 2016-06